MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK NOVUS PACKED

Catalog Number	10494134
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was raised to manufacturing who investigated the issue.Investigation concluded that this was an isolated incident caused by manual stacking of the cards during manufacturing.Due to this finding, manufacturing is ensuring that all cassettes that have not been automatically processed by the line will be checked by the visions system to ensure they are packaged correctly and an alert has been raised to ensure future cassettes are automatically processed.There have been no other complaints for this issue.
Event or Problem Description
The customer reported that in the box of the reagent cards (pro12) used on the novus, some were assembled in the opposite direction so that the test pads were read by the device in the incorrect order.The customer stated that they received incorrect protein results that were reported to the physician.The lab technician re-ran the samples and got correct results and a corrected report was issued.Siemens requested the results but they have not been provided.There was no report of injury due to this event.

• Brand Name: CLINITEK NOVUS PACKED
• Common Device Name: NOVUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7895822
• Report Number: 3002637618-2018-00109
• Device Sequence Number: 11389768
• Product Code: KQO
• UDI-Device Identifier: 00630414981130
• UDI-Public: 00630414981130
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10494134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1